Magnetocardiography (MCG) Device Use in Patients With Ele... | NCT06620744

Studies
Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin

NCT06620744

Sponsor

SB Technology, Inc.

Status

Completed

Last Update Posted

Jun 5, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

ACS - Acute Coronary Syndrome

Interventions

Sponsor MCG deivce

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2024Actual

Primary Completion Date

Apr 15, 2025Actual

Completion Date

Apr 15, 2025Actual

First Submitted Date

Sep 20, 2024

First Submission Date that Met QC Criteria

Sep 26, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sponsor MCG Device	Experimental	All participants will receive a scan from the sponsor's MCG device.	Device: Sponsor MCG deivce

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sponsor MCG deivce	Device	Unshielded device measuring cardiac magnetic fields.	Sponsor MCG Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.	MCG Data Quality	Per-scan, on average 5 minutes, day of enrollment

Secondary Outcomes

Measure	Description	Time Frame
Sandbox MCG safety	Device-related adverse events	30-days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)

Exclusion Criteria:

Present STEMI
Having an active atrial fibrillation episode as seen on 12-lead ECG
Clear non-ischemic cause for symptoms (e.g. trauma)
Active thoracic metal implants

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kit Yee Au-Yeung, PhD	SB Technology, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10019	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided